Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome

Obstructed Defecation Caused by Rectal Prolapse and Rectocele: Laparoscopic Ventral Rectopexy Alone Versus Laparoscopic Ventral Rectopexy Combined With Stapled Trans-anal Rectal Resection

Obstructed defecation syndrome (ODS) is a common problem in women. Rectal prolapse and rectocoele are frequently identified in patients with ODS. Surgery is the only definite treatment for those patients and is preferably performed minimally invasive. The most used procedures are laparoscopic ventral mesh rectopexy (LVMR) and stapled trans-anal rectal resection (STARR). However, high-level prospective studies on treatment strategies for ODS currently are lacking and, thus, no consensus exist regarding the optimal treatment for patients with ODS. This study aimed to compare LVMR alone and LVMR combined with STARR evaluating functional and anatomical results.

Study Overview

• Status: Recruiting
• Conditions: Chronic Constipation; Rectal Prolapse; Obstructive Defecation Syndrome
• Intervention / Treatment: Procedure: Modified Laparoscopic Ventral Mesh Rectopexy; Procedure: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Fu, MD; Phone Number: 86-13720120190; Email: futao1975@tom.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University
      • Contact: Tao Fu, MD; Phone Number: 86-13720120190; Email: futao1975@tom.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients affected by obstructed defecation with a minimum ODS score of 10
• External rectal prolapse or high-grade internal rectal prolapse
• Often experience excessive straining, sense of incomplete evacuation, and/or prolonged time for complete evacuation when attempting a bowel movement
• Have experienced ODS symptoms for at least 12 months prior to enrollment
• Failure of at least 6 months of medical therapy
• American Society of Anesthesiologists (ASA) score of no more than 3

Exclusion Criteria:

• Slow transit constipation
• Anismus resistant to conventional treatment
• No demonstrable pelvic anatomical problem
• Previous rectal or anal surgery
• Recto-vaginal fistula
• Pregnancy
• Previous pelvic radiotherapy
• Severe proctitis or significant rectal fibrosis
• Evidence of colorectal neoplasia, carcinoma, or inflammatory bowel disease
• Perineal infection
• High-grade endometriosis
• Morbid obesity
• A hostile abdomen
• Psychological instability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LVMR; Modified Laparoscopic Ventral Mesh Rectopexy	Procedure: Modified Laparoscopic Ventral Mesh Rectopexy; This group will undergo modified laparoscopic ventral mesh rectopexy alone
Experimental: LVMR with STARR; Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection	Procedure: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection; This group will undergo modified laparoscopic ventral mesh rectopexy combined with modified stapled trans-anal rectal resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the ODS score (ODS-S)	The primary outcome measure will be the change in total ODS score (ODS-S) measured at 12 months after surgery.	Baseline and 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Monitoring of complications started in the hospital and is followed up in the outpatient setting until 12 months after surgery.	0 to 12 months after surgery
Changes in the Patient Assessment of Constipation- Quality of Life score (PAC-QoL)	This is a measure of efficacy.	Baseline, 1, 3, 6, and 12 months after surgery
Changes in Health-Related Quality of Life	SF-36 version 1 will be used to measure changes in the health-related quality of life. This is a measure of efficacy.	Baseline, 1, 3, 6, and 12 months after surgery
Changes in Cleveland Clinic Fecal Incontinence Score (CCFI)	This is a measure of efficacy.	Baseline, 1, 3, 6, and 12 months after surgery
Changes in Fecal Incontinence Quality of Life Scale (FIQoL)	This is a measure of efficacy.	Baseline, 1, 3, 6, and 12 months after surgery
Radiological outcome as assessed by defecography	This is a measure of efficacy.	Baseline and 12 months after surgery
Changes in the ODS score (ODS-S)	This is a measure of efficacy.	Baseline, 1, 3, 6, and 12 months after surgery

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2017
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): April 1, 2026

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 18, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 12, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Pelvic Organ Prolapse; Syndrome; Prolapse; Constipation; Rectal Prolapse
• Other Study ID Numbers: LVMRSTARRODS2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No